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Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion (BRIGHTER)

Primary Purpose

Branch Retinal Vein Occlusion

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ranibizumab

Laser

About this trial

This is an interventional treatment trial for Branch Retinal Vein Occlusion focused on measuring Macular Edema, Branch Retinal Vein Occlusion, visual impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent must be obtained before any study assessment is performed
Diagnosis of visual impairment exclusively due to ME secondary to BRVO
BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)

Exclusion Criteria:

Pregnant or nursing (lactating) women
Stroke or myocardial infarction less than 3 months before Screening
Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline.
Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
Neovascularization of the iris or neovascular glaucoma in the study eye
Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
Focal or grid laser photocoagulation within 4 months before Baseline in the study eye
Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye
Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

1-ranibizumab monotherapy

2-ranibizumab with laser

3-laser monotherapy

Arm Description

Ranibizumab 0.5 mg

Ranibizumab 0.5 mg + laser

Laser monotherapy with Ranibizumab 0.5 mg from Month 6

Outcomes

Primary Outcome Measures

Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.

Secondary Outcome Measures

The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients.

Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group

Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data.

Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients.

The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model.

The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 6 & Month 24 as compared with baseline, was assessed by an ANOVA model. Endpoints related to the proportion of patients with BCVA letter gain or loss from Baseline was analyzed via stratified Cochran-Mantel-Haenszel test with stratification based on baseline BCVA (baseline BCVA less than or equal to 39, 40 to 59, greater than or equal to 60 letters, treatment groups).

Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye

Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 6 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 6 indicates a positive outcome.

Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye

Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 24 indicates a positive outcome.

The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm

Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation. Stratification was done based on categories of baseline best corrected visual acuity & analysis was based on analysis of variance (ANOVA)

The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline

The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.

BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.

Full Information

NCT ID

NCT01599650

First Posted

May 2, 2012

Last Updated

September 21, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01599650

Brief Title

Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion

Acronym

BRIGHTER

Official Title

A 24-month, Phase IIIb, Open-label, Randomized, Active Controlled, 3-arm, Multicenter Study Assessing the Efficacy and Safety of an Individualized, Stabilization-criteria-driven PRN Dosing Regimen With 0.5-mg Ranibizumab Intravitreal Injections Applied as Monotherapy or With Adjunctive Laser Photocoagulation in Comparison to Laser Photocoagulation in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Branch Retinal Vein Occlusion

Keywords

Macular Edema, Branch Retinal Vein Occlusion, visual impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

455 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1-ranibizumab monotherapy

Arm Type

Experimental

Arm Description

Ranibizumab 0.5 mg

Arm Title

2-ranibizumab with laser

Arm Type

Experimental

Arm Description

Ranibizumab 0.5 mg + laser

Arm Title

3-laser monotherapy

Arm Type

Active Comparator

Arm Description

Laser monotherapy with Ranibizumab 0.5 mg from Month 6

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Type

Procedure

Intervention Name(s)

Laser

Intervention Description

laser photocoagulation

Primary Outcome Measure Information:

Title

Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)

Description

Time Frame

Baseline, 6 Months

Secondary Outcome Measure Information:

Title

The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline

Description

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients.

Time Frame

Baseline, 24 Months

Title

Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group

Description

Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data.

Time Frame

Day 1 through Month 23

Title

Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6

Description

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients.

Time Frame

From Baseline through Month 6

Title

The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24

Description

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model.

Time Frame

Baseline, Month 12 and Month 24

Title

The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit

Description

Time Frame

Baseline, Month 6 and Month 24

Title

Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye

Description

Time Frame

Month 6

Title

Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye

Description

Time Frame

Month 24

Title

The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm

Description

Time Frame

Month 12 and Month 24

Title

The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline

Description

Time Frame

Months 6 and 24

Title

BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm

Description

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.

Time Frame

Month 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent must be obtained before any study assessment is performed Diagnosis of visual impairment exclusively due to ME secondary to BRVO BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS) Exclusion Criteria: Pregnant or nursing (lactating) women Stroke or myocardial infarction less than 3 months before Screening Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline. Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye Neovascularization of the iris or neovascular glaucoma in the study eye Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye Focal or grid laser photocoagulation within 4 months before Baseline in the study eye Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Parramatta

State/Province

New South Wales

ZIP/Postal Code

2150

Country

Australia

Facility Name

Novartis Investigative Site

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2000

Country

Australia

Facility Name

Novartis Investigative Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Novartis Investigative Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2H0C8

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 4X3

Country

Canada

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4G5

Country

Canada

Facility Name

Novartis Investigative Site

City

Boisbriand

State/Province

Quebec

ZIP/Postal Code

J7H 1S6

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Novartis Investigative Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Glostrup

ZIP/Postal Code

DK-2600

Country

Denmark

Facility Name

Novartis Investigative Site

City

Dijon

ZIP/Postal Code

21033

Country

France

Facility Name

Novartis Investigative Site

City

Lyon

ZIP/Postal Code

69003

Country

France

Facility Name

Novartis Investigative Site

City

Nice

ZIP/Postal Code

06000

Country

France

Facility Name

Novartis Investigative Site

City

Paris cedex 10

ZIP/Postal Code

75010

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 19

ZIP/Postal Code

75940

Country

France

Facility Name

Novartis Investigative Site

City

Paris

Country

France

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

124 62

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion Crete

State/Province

ZIP/Postal Code

711 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Larissa

State/Province

ZIP/Postal Code

411 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

546 29

Country

Greece

Facility Name

Novartis Investigative Site

City

Patras

ZIP/Postal Code

26504

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

GR 54636

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1133

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

H-1083

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Dublin 7

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

Country

Ireland

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20100

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00144

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10122

Country

Italy

Facility Name

Novartis Investigative Site

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Novartis Investigative Site

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

Novartis Investigative Site

City

Leiden 2333 ZA

ZIP/Postal Code

2333

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3011 BH

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Bielsko-Biala

ZIP/Postal Code

43-300

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-809

Country

Poland

Facility Name

Novartis Investigative Site

City

Kraków

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-079

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-005

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-556

Country

Poland

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000-354

Country

Portugal

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3030-163

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1050-085

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1349-019

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Zilina

State/Province

Slovak Republic

ZIP/Postal Code

010 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Banska Bystrica

ZIP/Postal Code

975 17

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

851 07

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Valladolid

State/Province

Castilla y Leon

ZIP/Postal Code

47011

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08022

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluña

Country

Spain

Facility Name

Novartis Investigative Site

City

L´Hospitalet de Llobregat

State/Province

Cataluña

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03016

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46014

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46015

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Bilbao

State/Province

Pais Vasco

ZIP/Postal Code

48006

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Örebro

ZIP/Postal Code

701 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3012

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

1007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Olten

ZIP/Postal Code

4600

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zuerich

ZIP/Postal Code

8063

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Frimley

State/Province

Surrey

ZIP/Postal Code

GU16 7UJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Belfast

ZIP/Postal Code

BT12 6BA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bristol

ZIP/Postal Code

BS1 2LX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC1V 2PD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW1 5QH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Plymouth

ZIP/Postal Code

PL4 6PL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

34934034

Citation

Pawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385.

Results Reference

derived

PubMed Identifier

28807635

Citation

Tadayoni R, Waldstein SM, Boscia F, Gerding H, Gekkieva M, Barnes E, Das Gupta A, Wenzel A, Pearce I; BRIGHTER Study Group. Sustained Benefits of Ranibizumab with or without Laser in Branch Retinal Vein Occlusion: 24-Month Results of the BRIGHTER Study. Ophthalmology. 2017 Dec;124(12):1778-1787. doi: 10.1016/j.ophtha.2017.06.027. Epub 2017 Aug 12. Erratum In: Ophthalmology. 2018 Mar;125(3):463.

Results Reference

derived

PubMed Identifier

27039022

Citation

Tadayoni R, Waldstein SM, Boscia F, Gerding H, Pearce I, Priglinger S, Wenzel A, Barnes E, Gekkieva M, Pilz S, Mones J; BRIGHTER study group. Individualized Stabilization Criteria-Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion: Six-Month Results of BRIGHTER. Ophthalmology. 2016 Jun;123(6):1332-44. doi: 10.1016/j.ophtha.2016.02.030. Epub 2016 Mar 30.

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Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion

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Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion (BRIGHTER)

Branch Retinal Vein Occlusion

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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